Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:54 PM
Ignite Modification Date: 2025-12-25 @ 2:37 PM
NCT ID: NCT03111550
Description: The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03111550
Study Brief: Clinical Investigation of the Next-Generation Intraocular Lens
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tecnis ZHR00 Investigational Lens Device 2 None 8 78 4 78 View
ZQR00 Investigational Lens Device 0 None 7 73 3 73 View
ZXR00 Control Lens Device 1 None 5 79 3 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Retinal tear and repair NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Blood Clot in leg requiring emergency angioplasty NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Secondary Surgical Intervention: IOL removal NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Cystoid Macular Edema NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Lung Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chronic Obstructive Pulmonary Disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hernia Surgical repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Retinal Detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diverticulitis of Large intestine with perforation resulting in hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lens removal due to undesired optical phenomena due to fixed pupil NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Heart Attack NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death during sleep NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to surgical removal of tumors NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Death secondary to cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospitalization due to weakness secondary to cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospitalization due to hip fracture secondary to fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization due to cholecystectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop NON_SYSTEMATIC_ASSESSMENT Product Issues None View